8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) October 30, 2007
ENZON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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0-12957
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22-2372868 |
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(State or other jurisdiction of incorporation)
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(Commission File No.)
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(IRS Identification No.) |
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685 Route 202/206, Bridgewater, New Jersey
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08807 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code (908) 541-8600
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b) |
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
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Item 2.02 |
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Results of Operations and Financial Condition. |
On October 30, 2007, Enzon Pharmaceuticals, Inc. (Enzon) issued a press release reporting certain
financial and other information for the quarter ended September 30, 2007. A copy of Enzons press
release dated October 30, 2007, is attached as Exhibit 99.1 to this Current Report and is
incorporated by reference into this Item 2.02.
In addition, Enzon will broadcast live by webcast its Investor Day meeting from approximately 8:30
a.m. to 1:00 p.m. Eastern Time on Tuesday, October 30, 2007. During the meeting, members of
Enzons executive management team and heads of various research and development programs will
provide updates on the status of several programs currently underway, as well as earnings for the
quarter ended September 30, 2007. The meeting will be webcast via the internet at
http://www.vcall.com/IC/CEPage.asp?ID=122287 and an archived replay will be available after the
event until Friday, November 30, 2007 at approximately 12:01 am Eastern Time. Listeners should log
on to the website at least fifteen minutes before this event to download and install any necessary
audio software.
The information in this Item 2.02, including Exhibit 99.1, is being furnished and shall not be
deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the
Exchange Act) or otherwise subject to the liability of that Section, nor shall such information
be deemed to be incorporated by reference into any registration statement or other document filed
under the Securities Act of 1933 or the Exchange Act, except as otherwise stated in that filing.
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Item 9.01 |
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Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1
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Press Release of Enzon Pharmaceuticals, Inc. dated October 30, 2007 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: October 30, 2007
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By: |
/s/ Craig A. Tooman
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Craig A. Tooman |
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Executive Vice President, Finance and
Chief Financial Officer |
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EX-99.1
Exhibit 99.1
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For Immediate Release |
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Contact:
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Craig Tooman |
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EVP, Finance and Chief
Financial Officer |
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908-541-8777 |
ENZON REPORTS THIRD QUARTER 2007 RESULTS
Partial royalty sale provides positive earnings and cash to eliminate outstanding 2008 debt
BRIDGEWATER, NJ October 30, 2007 Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced its
financial results for the third quarter of 2007. For the three months ended September 30, 2007,
Enzon reported net income of $87.5 million or $1.23 per diluted share, as compared to net income of
$2.2 million or $0.05 per diluted share for the same quarter in 2006. Third quarter results in
2007 were favorably impacted by the August 2007 sale of a 25% interest in future royalties from
PEG-INTRON®, marketed by Schering-Plough Corporation, for $92.5 million ($88.7 million net of
related costs) to DRI Capital (DRI).
The sale of a portion of our PEG-INTRON royalty this quarter was a very strategic financing move
to effectively eliminate the outstanding 2008 debt burden, while still preserving the majority of
the royalty stream, said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. We
are also focused on the advancement of our innovative pipeline, such as the HIF-1a antagonist and
PEG-SN38 programs, which demonstrates our strong commitment to developing a differentiated oncology
portfolio for the benefit of patients.
Financial Results
For the three months ended September 30, 2007 and 2006, Enzon reported an adjusted net loss of $1.3
million or $0.03 per diluted share.
Revenues
The following table reflects the revenues generated by product and segment for each of the
three-month periods ended September 30, 2007 and 2006.
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Three Months Ended |
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(in thousands) |
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September 30, |
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September 30, |
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2007 |
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2006 |
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% Change |
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Products |
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Oncaspar |
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$ |
10,520 |
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$ |
7,418 |
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42 |
% |
DepoCyt |
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2,163 |
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2,000 |
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8 |
% |
Abelcet |
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6,743 |
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8,986 |
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-25 |
% |
Adagen |
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5,448 |
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6,891 |
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-21 |
% |
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Total Products |
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$ |
24,874 |
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$ |
25,295 |
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-2 |
% |
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Royalties |
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$ |
18,206 |
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$ |
18,705 |
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-3 |
% |
Contract Manufacturing |
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$ |
3,761 |
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$ |
1,856 |
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103 |
% |
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Total Revenues |
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$ |
46,841 |
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$ |
45,856 |
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2 |
% |
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Products Segment
Sales from the products segment, comprised of Oncaspar®, DepoCyt®,
Abelcet®, and Adagen®, decreased slightly to $24.9 million for the
three months ended September 30, 2007, from $25.3 million for the three months ended September 30,
2006. The Company continues to experience revenue growth in its oncology products, Oncaspar and
DepoCyt, offsetting the decline in Abelcet and Adagen sales.
Sales of Oncaspar grew to $10.5 million or 42 percent for the three months ended September 30,
2007, as compared to $7.4 million for the three months ended September 30, 2006. The growth is
attributable to the adoption of Oncaspar in certain new cooperative group protocols in pediatrics
and adult patients that call for dosage regimens that will include a greater number of weeks of
Oncaspar therapy, as well as a price increase. The Company is studying Oncaspar in a Phase I trial
in combination with gemcitabine for patients with solid tumors and lymphoma.
Sales of DepoCyt, increased to $2.2 million or 8 percent for the three months ended September 30,
2007, as compared to $2.0 million for the three months ended September 30, 2006. In April 2007, the
FDA granted full approval of DepoCyt. Originally DepoCyt was approved under the FDAs Sub Part H
regulation. Given the small number of patients treated with DepoCyt, quarterly sales variability
will likely continue.
Sales of Abelcet in the U.S. and Canada for the three months ended September 30, 2007 were $6.7
million, down 25 percent as compared to $9.0 million for the three months ended September 30, 2006.
This volume decrease was due to the continued competitive conditions in the antifungal market.
Sales of Adagen decreased 21 percent to $5.4 million for the three months ended September 30, 2007,
as compared to $6.9 million for the three months ended September 30, 2006. This market has a very
small number of patients so quarter-to-quarter variability is not uncommon.
Royalties Segment
Revenues from the Companys Royalties segment for the three months ended September 30, 2007 were
$18.2 million, as compared to $18.7 million for the three months ended September 30, 2006, a
decrease of 3 percent. The decrease in royalties was primarily due to the decrease in royalties
from Macugen. Macugen has experienced increased competition since the launch of a new agent in
2006. The decrease in Macugen royalties was partially offset by growth in PEG-INTRON. As previously
stated, the Company sold a 25% interest in its future royalties on PEG-INTRON for $92.5 million,
which resulted in an $88.7 million gain in the royalty segment. Starting in the fourth quarter of
2007 and beyond, the royalty segment will be impacted by the 25% reduction in PEG-INTRON royalties
recorded.
Contract Manufacturing Segment
The Companys revenues from its Contract Manufacturing segment were $3.8 million for the three
months ended September 30, 2007, as compared to $1.9 million in the corresponding period of the
prior year. The contract manufacturing segment includes contract manufacturing revenues related to
services the Company provides for a number of customers who require injectable products, such as
Abelcet for markets outside of Canada and the U.S. The increase in contract manufacturing revenue
this quarter is due to a revenue reconciliation for two contract manufacturing products in the
third quarter of 2006 which resulted in a reduction of revenue of $1.2 million. The timing of
shipment to third parties also resulted in higher revenues for the quarter.
Cost of Product Sales and Contract Manufacturing
The Companys cost of goods sold was $14.1 million for the three months ended September 30, 2007,
compared to $12.1 million for the three months ended September 30, 2006. This increase is due in
part to additional amortization expense for the license of the raw material used in the production
of Oncaspar and additional royalties for the growth in Oncaspar sales.
Research and Development
The Companys research and development expenses were $10.8 million for the three months ended
September 30, 2007, as compared to $10.6 million for the three months ended September 30, 2006.
The expenses are associated with the clinical trials and process development activities currently
underway for four of the Companys product candidates in development the HIF-1 alpha antagonist,
PEG-SN38, rhMBL and additional uses for Oncaspar. Enzon continues to advance its novel and
differentiated oncology pipeline.
Selling, General and Administrative
Selling, general and administrative expenses were $14.3 million for the third quarter of 2007,
essentially unchanged from the same period last year. The Company continues to make select
investments in selling, marketing, and other initiatives to further its objective of delivering
long-term value.
Acquired In-Process Research and Development
In August 2006, the Company paid $8.0 million for worldwide rights to develop and commercialize
certain RNA antagonists.
Restructuring Charge
The Company announced in February 2007 plans to consolidate its manufacturing sites. As a result
of this decision, the Company recorded a $5.5 million charge this quarter, of which $5.1 million
relates to the write-off of assets associated with a portion of our South Plainfield facility that
are being decommissioned. The remaining balance is associated with the accrual of severance costs.
On a year-to-date basis, we have recognized $6.8 million, of which $1.7 million relates to
severance costs that will be paid at the completion of the consolidation and $5.1 million related
to the write-off of assets. The Company has also incurred $1.9 million in expenses earlier this
year related to validation batches, which were recorded in cost of product sales and contract
manufacturing, bringing the total cost in 2007 associated with the consolidation to $8.7 million.
As previously reported, the Company expects to incur $8.0 million to $10.0 million in 2007 in the
process of consolidating our manufacturing at our Indianapolis facility.
Gain on Sale of Royalty Interest
During the three months ended September 30, 2007, we sold a 25% interest in our future royalty
revenues on sales of PEG-INTRON. The gross selling price was $92.5 million. The gain on the sale
of $88.7 million, after deducting related costs of the transaction, was recognized in full in our
Royalties segment in the third quarter of 2007.
Income Tax Provision
A federal income tax provision of $2.0 million was recorded for the three months ended September
30, 2007, which represents federal alternative minimum tax, primarily related to the gain on the
sale of the royalty interest.
Other Income (Expense)
Net other income (expense) is comprised of investment income, interest expense, and other
non-operating expenses. The Company reported other expense of approximately $1.1 million for the
three months ended September 30, 2007, as compared to other income of nearly $1.8 million in the
same period in the prior year. In 2006, the Company reported a net gain of $3.6 million as a
result of the repurchase of 2008 debt at a discount to par.
Cash and Investments
Total cash reserves, which include cash, cash equivalents, short-term investments, marketable
securities, and restricted investments and cash, were $261.3 million as of September 30, 2007, as
compared to $240.6 million as of December 31, 2006. During this quarter, the Company purchased
$24.8 million of its existing 2008 convertible notes. This quarter we received $92.5 million as a
result of the sale of 25% of our royalty interest in PEG-INTRON. $82.0 million of the proceeds is
held in a restricted cash account for the sole purpose of extinguishing the remaining outstanding
2008 debt.
Reconciliation of GAAP net income (loss) to adjusted net income (loss)
The following table reconciles the Companys net income and net income per diluted share as
determined in accordance with U.S. generally accepted accounting principles (GAAP) to its adjusted
net loss and net loss per diluted share for the three months ended September 30, 2007 and 2006
respectively:
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Three Months Ended |
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(in thousands, except per-share amounts) |
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September 30, 2007 |
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September 30, 2006 |
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Net |
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income |
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Net ncome |
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Net |
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(loss) per |
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Net |
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(loss) per |
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income |
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diluted |
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income |
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diluted |
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(loss) |
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share |
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(loss) |
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share |
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GAAP net income |
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$ |
87,530 |
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$ |
1.23 |
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$ |
2,238 |
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$ |
0.05 |
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Net adjustments to GAAP: |
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- Net realized gain related to the repurchase
of debt (1) |
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(182 |
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(3,569 |
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(0.08 |
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- Gain on sale of royalty interest
(2) |
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(88,666 |
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(1.26 |
) |
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Adjusted net loss(3) |
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$ |
(1,318 |
) |
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$ |
(0.03 |
) |
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$ |
(1,331 |
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$ |
(0.03 |
) |
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(1) |
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The Companys adjusted financial results exclude gains related to the repurchase of the 4.5% Notes at
a price at a discount to par (plus accrued interest), offset by a write-off of related debt offering costs. |
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(2) |
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The Companys adjusted financial results for the third quarter of 2007 exclude a gain on the sale of
a 25% interest in future royalties on sales of PEG-INTRON by Schering-Plough Corporation of $88.7 million. The
per-share effect of this adjustment was derived by subtracting the discrete computation of diluted earnings per share
on the adjusted net loss from the GAAP net income per share. |
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(3) |
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Adjusted net loss and adjusted net loss per share, as Enzon defines them, may differ from similarly
named measures used by other entities, and consequently, could be misleading unless all entities calculated and
defined such items in the same manner. The Company believes that investors understanding of its performance is
enhanced by disclosing adjusted net loss and adjusted net loss per share reflecting adjustments for certain items
that the Company deems to be non-recurring. |
About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development,
manufacturing, commercialization of important medicines for patients with cancer and other
life-threatening conditions. Enzon has a portfolio of four marketed products, Oncaspar®,
DepoCyt®, Abelcet® and Adagen®. The Companys drug development
programs utilize several cutting-edge approaches, including its industry-leading PEGylation
technology platform used to create product candidates with benefits such as reduced dosing
frequency and less toxicity. Enzons PEGylation technology was used to develop two of its products,
Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other
products developed using the technology. Enzon also engages in contract manufacturing for several
pharmaceutical companies to broaden the Companys revenue
base. Further information about Enzon and this press release can be found on the Companys web site
at www.enzon.com.
Forward Looking Statements
There are forward-looking statements contained herein, which can be identified by the use of
forward-looking terminology such as the words believes, expects, may, will, should,
potential, anticipates, plans or intends and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future results, events or
developments indicated in such forward-looking statements. Such factors include, but are not
limited to the timing, success and cost of clinical studies; the ability to obtain regulatory
approval of products, market acceptance of, and continuing demand for, Enzons products and the
impact of competitive products and pricing. A more detailed discussion of these and other factors
that could affect results is contained in our filings with the U.S. Securities and Exchange
Commission, including our annual report on Form 10-K for the year ended December 31, 2006 and our
quarterly reports on Form 10-Q. These factors should be considered carefully and readers are
cautioned not to place undue reliance on such forward-looking statements. No assurance can be
given that the future results covered by the forward-looking statements will be achieved. All
information in this press release is as of the date of this press release and Enzon does not intend
to update this information.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
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Three months ended |
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September 30, |
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2007 |
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2006 |
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Revenues: |
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Product sales, net |
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$ |
24,874 |
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$ |
25,295 |
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Royalties |
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18,206 |
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|
18,705 |
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Contract manufacturing |
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3,761 |
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1,856 |
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Total revenues |
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46,841 |
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45,856 |
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Costs and expenses: |
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Cost of product sales and contract manufacturing |
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14,118 |
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12,141 |
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Research and development |
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10,814 |
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10,599 |
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Selling, general and administrative |
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14,274 |
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14,299 |
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Amortization of acquired intangible assets |
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171 |
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184 |
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Acquired in-process research and development |
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8,000 |
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Restructuring charge |
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5,513 |
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Total costs and expenses |
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44,890 |
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45,223 |
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Gain on sale of royalty interest, net |
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88,666 |
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Operating income |
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90,617 |
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|
633 |
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Other income (expense): |
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Investment income, net |
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2,689 |
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2,831 |
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Interest expense |
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(4,286 |
) |
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(5,912 |
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Other, net |
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497 |
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4,813 |
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(1,100 |
) |
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1,732 |
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Income before income tax provision |
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89,517 |
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2,365 |
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Income tax provision |
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1,987 |
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127 |
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Net income |
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$ |
87,530 |
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$ |
2,238 |
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Earnings per common share basic |
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$ |
1.99 |
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$ |
0.05 |
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Earnings per common share diluted |
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$ |
1.23 |
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$ |
0.05 |
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Weighted average shares basic |
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43,925 |
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43,590 |
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Weighted average shares diluted |
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74,344 |
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43,590 |
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
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September 30, |
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December 31, |
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2007 |
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2006 |
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ASSETS |
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Current assets: |
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Cash and short-term investments |
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$ |
162,889 |
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$ |
173,544 |
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Restricted investments and cash |
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82,156 |
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Accounts receivable, net |
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|
13,788 |
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|
15,259 |
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Inventories |
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|
20,627 |
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|
17,618 |
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Other current assets |
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6,918 |
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|
5,890 |
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Total current assets |
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286,378 |
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|
212,311 |
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Property and equipment, net |
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44,790 |
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|
39,491 |
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Other assets: |
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Marketable securities |
|
|
16,277 |
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|
|
67,061 |
|
Amortizable intangible assets, net |
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|
70,723 |
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|
78,510 |
|
Other assets |
|
|
5,350 |
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|
|
6,457 |
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Total assets |
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$ |
423,518 |
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|
$ |
403,830 |
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LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
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Current liabilities: |
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|
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Accounts payable and accrued expenses |
|
$ |
29,786 |
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|
$ |
59,885 |
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Notes payable |
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|
81,921 |
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Total current liabilities |
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111,707 |
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|
|
59,885 |
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Notes payable |
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|
275,000 |
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|
397,642 |
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Other liabilities |
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|
3,165 |
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|
|
2,744 |
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Total liabilities |
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|
389,872 |
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|
|
460,271 |
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Stockholders equity (deficit) |
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33,646 |
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(56,441 |
) |
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Total liabilities and
stockholders equity (deficit) |
|
$ |
423,518 |
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|
$ |
403,830 |
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Common shares outstanding |
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|
44,106 |
|
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|
43,999 |
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